The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/25/2017
Start Date:December 2009
End Date:April 2014

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A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).

This study will test whether darapladib can safely lower the chances of having a
cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g.
medical procedures performed to restore the normal blood flow in patients with
atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome
(also called ACS).

Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo
administered in addition to standard therapy. Following the baseline visit, subjects will be
expected to return for clinic visits at 1 month, 3 months, 6 months and every 6 months until
the end of the study.

Inclusion Criteria:

- Signed written informed consent.

- Men or women at least 18 years old (in Taiwan, at least 20 years old). Women must be
post-menopausal or using a highly effective method for avoidance of pregnancy.

- Hospitalization for acute coronary syndrome (ACS) within 30 days prior to study
entry.

- Clinically stable for 24 hours prior to study entry.

- A planned percutaneous coronary intervention (PCI) should be performed prior to study
entry, whenever possible.

- At least one of the following:

- At least 60 years old.

- Myocardial infarction prior to the qualifying ACS event.

- Diabetes mellitus requiring treatment with medication.

- Diagnosed mild or moderate reduction in kidney function.

- Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months
prior to study entry) OR peripheral artery disease.

Exclusion Criteria:

- ACS symptoms or lab results not believed to be caused by a narrowing or blocked
coronary artery.

- No major coronary artery with a blockage of more than 50% (unless all stenoses are
successfully treated by PCI).

- Planned coronary artery bypass graft (CABG) surgery, or CABG surgery performed after
the qualifying ACS event and prior to study entry.

- Certain types of liver disease.

- Severe reduction in kidney function OR removal of a kidney OR kidney transplant.

- Severe heart failure.

- Blood pressure higher than normal despite lifestyle changes and treatment with
medications.

- Any life-threatening disease with a life expectancy of less than 2 years (other than
heart disease) that may prevent the subject from completing the study.

- Severe asthma that is poorly controlled with medication.

- Pregnancy (Note: A pregnancy test will be performed on all non-sterile women prior to
study entry).

- Previous severe allergic reaction to food, medications, drink, insect stings, etc.

- Drug or alcohol abuse within the past 6 months. Mental/psychological impairment that
may prevent the subject from complying with study procedures or understanding the
goal and potential risks of participating in the study.

- Certain medications that may interfere with the study medication (these will be
identified by the study doctor).

- If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must
have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less
than or equal to 20.0 nmol/min/mL are excluded.

- Previously took darapladib (SB-480848).

- Participation in a study of an investigational medication within the past 30 days.

- Current participation in a study of an investigational device.

- Any other reason the investigator deems the subject should not participate in the
study.
We found this trial at
259
sites
Alexandria, Louisiana 71301
1494
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Alexandria, LA
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Albany, New York 12206
2438
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Albuquerque, New Mexico 87109
654
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Albuquerque, NM
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Allentown, Pennsylvania 18102
2356
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Allentown, PA
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Amarillo, Texas 79106
918
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Amarillo, TX
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Anchorage, Alaska 99508
2341
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Anchorage, AK
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Ann Arbor, Michigan 48109
1934
mi
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Ann Arbor, MI
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Asheville, North Carolina 28803
2003
mi
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Asheville, NC
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Atlanta, Georgia 30341
1922
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Atlanta, GA
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Atlantis, Florida 33462
2305
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Atlantis, FL
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Augusta, Georgia 30909
2053
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Augusta, GA
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Aurora, Illinois 60504
1698
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Aurora, IL
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Austin, Texas 78705
1211
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Austin, TX
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Aventura, Florida 33180
2320
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Aventura, FL
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Avon, Indiana 46123
1780
mi
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Avon, IN
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Ayer, Massachusetts 01432
2550
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Ayer, MA
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Bakersfield, California 93309
106
mi
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Bakersfield, CA
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Baltimore, Maryland 21201
2301
mi
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Baltimore, MD
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Bangor, Maine 04401
2685
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Bangor, ME
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Bannockburn, Illinois 60015
1721
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Bannockburn, IL
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Beaver, Pennsylvania 15009
2103
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Beaver, PA
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Bel Air, Maryland 21014
2314
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Bel Air, MD
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Bellevue, Washington 98004
961
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Bellevue, WA
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Bellingham, Washington 98225
1040
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Beloit, Wisconsin 53511
1666
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Beloit, WI
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Bethlehem, Pennsylvania 18105
2356
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Bethlehem, PA
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Beverly Hills, California 90211
21
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Beverly Hills, CA
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Birmingham, Alabama 35249
1777
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Birmingham, AL
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Boise, Idaho 83712
665
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Boise, ID
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Boston, Massachusetts 02115
2578
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Boston, MA
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Brandon, Florida 33511
2146
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Brandon, FL
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Bridgeport, Connecticut 06606
2472
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Bridgeport, CT
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Bronx, New York 10461
2441
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Brooklyn, New York 11215
2434
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Brooklyn, NY
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Browns Mills, New Jersey 08015
2406
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Buffalo, New York 14263
2181
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Burien, Washington 98166
952
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Burien, WA
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Burlington, North Carolina 27215
2171
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Burlington, NC
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Camp Hill, Pennsylvania 17011
2281
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Camp Hill, PA
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Canton, Ohio 44708
2043
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Canton, OH
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Capital Federal, Buenos Aires
6113
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Capital Federal,
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Chambersburg, Pennsylvania 17201
2243
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Chambersburg, PA
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Charleston, South Carolina 29425
2184
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Charlotte, North Carolina 28203
2100
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Chattanooga, Tennessee 37421
1862
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Chicago, Illinois 60611
1730
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Chicago, IL
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Cincinnati, Ohio 45229
1880
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Clearwater, Florida 33759
2122
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Cleveland, Ohio 44195
2036
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Colorado Springs, Colorado 80910
804
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Columbia, Maryland 21044
2287
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Columbia, Missouri 65201
1459
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Columbia, Montana 65201
1460
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Columbia, South Carolina 29203
2102
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Columbia, Tennessee 38401
1752
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Concord, North Carolina 28025
2114
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Corpus Christi/Texas, Texas 78404
1294
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Cortlandt Manor, New York 10567
2437
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Cottonwood, Arizona 86326
345
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Crestview Hill, Kentucky 41017
1877
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Cumming, Georgia 30041
1927
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Dallas, Texas 75230
1223
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Dayton, Ohio 45420
1900
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Daytona Beach, Florida 32117
2186
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Dearborn, Michigan 48126
1960
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Detroit, Michigan 48202
1965
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Doylestown, Pennsylvania 18901
2375
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Duluth, Minnesota 55805
1610
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Elizabeth, New Jersey 07201
2422
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Elizabeth, NJ
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Elmer, New Jersey 08318
2376
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Elyria, Ohio 44035
2010
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Erie, Pennsylvania 16507
2116
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Everett, Washington 98201
986
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Fairfield, Ohio 45014
1877
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Fairview Park, Ohio 44126
1878
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Fall River, Massachusetts 02720
2578
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Fleming Island, Florida 32003
2131
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Flint, Michigan 48504
1936
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Flint, MI
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Fort Lauderdale, Florida 33308
2315
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Fort Smith, Arkansas 72903
1342
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Fort Wayne, Indiana 46825
1853
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Fort Worth, Texas 76104
1195
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Fresno, California 93720
216
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Gainesville, Florida 32610
2105
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Galveston, Texas 77555
1401
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Gastonia, North Carolina 28054
2084
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Glendale, Arizona 85304
336
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Glendale, California 91204
14
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Golden, Colorado 80401
807
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Grand Forks, North Dakota 58201
1444
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Grand Island, Nebraska 68803
1171
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Great Falls, Montana 59405
990
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Greeley, Colorado 80631
851
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Green Bay, Wisconsin 54301
1745
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Green Bay, WI
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Greensboro, North Carolina 27403
2150
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Greenville, South Carolina 29615
2022
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Greenville, SC
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Guilford, Connecticut 06437
2499
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Guilford, CT
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Gulf Breeze, Florida 32561
1814
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Gulf Breeze, FL
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Haddon Heights, New Jersey 08035
2381
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Hammond, Indiana 46320
1733
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Hammond, IN
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Harker Heights, Texas 76548
1200
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Harker Heights, TX
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